Key information relevant to the recruitment process for the
overall study, such as dates of the recruitment period and locations

Multicenter, global clinical trial

Pre-Assignment Details

Significant events and approaches for the overall study
following participant enrollment, but prior to group assignment

Patients were randomized 2:1 to receive either Enzalutamide or placebo

Reporting Groups

Description

Enzalutamide

Participants received 160 mg Enzalutamide orally per day. Treatment continued until unacceptable toxicity, confirmed disease progression and the patient was scheduled to initiate a new systemic antineoplastic therapy, death, or withdrawal.

Placebo

Participants received placebo tablets orally once a day. Treatment continued until unacceptable toxicity, confirmed disease progression and the patient was scheduled to initiate a new systemic antineoplastic therapy, death, or withdrawal.

Participant Flow: Overall Study

Enzalutamide

Placebo

STARTED

800

399

COMPLETED

254
[1]

163
[1]

NOT COMPLETED

546

236

Lost to Follow-up

1

1

Death

305

211

Withdrawal of consent

9

5

Continuing Treatment

231

19

[1]

Indicates participants continuing long-term follow-up as of 25 September 2011.

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

No text entered.

Reporting Groups

Description

Enzalutamide

Participants received 160 mg Enzalutamide orally per day. Treatment continued until unacceptable toxicity, confirmed disease progression and the patient was scheduled to initiate a new systemic antineoplastic therapy, death, or withdrawal.

Placebo

Participants received placebo tablets orally once a day. Treatment continued until unacceptable toxicity, confirmed disease progression and the patient was scheduled to initiate a new systemic antineoplastic therapy, death, or withdrawal.

Survival is defined as time from randomization to death due to any cause. The duration of overall survival was right-censored for patients who were lost to follow-up since randomization or not known to have died at the data analysis cutoff date (this included patients who were known to have died after the data analysis cutoff date).

Time Frame

During study period (up to 3 years)

Safety Issue

No

Population Description

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

Intent to Treat (ITT) - All Patients Randomized

Reporting Groups

Description

Enzalutamide

Participants received 160 mg Enzalutamide orally per day. Treatment continued until unacceptable toxicity, confirmed disease progression and the patient was scheduled to initiate a new systemic antineoplastic therapy, death, or withdrawal.

Placebo

Participants received placebo tablets orally once a day. Treatment continued until unacceptable toxicity, confirmed disease progression and the patient was scheduled to initiate a new systemic antineoplastic therapy, death, or withdrawal.

Measured Values

Enzalutamide

Placebo

Number of Participants Analyzed
[units: participants]

800

399

Overall Survival
[units: Months]Median ( 95% Confidence Interval )

18.4
( 17.3 to NA )
[1]

13.6
( 11.3 to 15.8 )

[1]

The upper limit of the 95% confidence interval was not calculable because an insufficient number of participants reached the event at the final time point for assessment

Statistical Analysis 1 for Overall Survival

Groups [1]

All groups

Method [2]

Log Rank

P Value [3]

<0.0001

Hazard Ratio (HR) [4]

0.63

95% Confidence Interval

( 0.53 to 0.75 )

[1]

Additional details about the analysis, such as null hypothesis and power calculation:

No text entered.

[2]

Other relevant method information, such as adjustments or degrees of freedom: